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Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

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ClinicalTrials.gov Identifier: NCT01700192
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : March 3, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
ALK-Abelló A/S

Study Description
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Brief Summary:

The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).


Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Rhinitis, Allergic, Nonseasonal Biological: MK-8237 tablets Biological: Placebo tablets Drug: Rescue Medication: Self-Injectable Epinephrine Drug: Rescue Medication: Loratadine tablets Drug: Rescue Medication: Olopatadine ophthalmic drops Drug: Rescue Medication: Mometasone furoate nasal spray Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
Study Start Date : January 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: MK-8237
MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
 Biological: MK-8237 tablets
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Other Name: SCH 900237

Drug: Rescue Medication: Self-Injectable Epinephrine
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.

Drug: Rescue Medication: Loratadine tablets
Loratadine tablet 10 mg administered orally as needed for rescue medication.

Drug: Rescue Medication: Olopatadine ophthalmic drops
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.

Drug: Rescue Medication: Mometasone furoate nasal spray
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Placebo Comparator: Placebo
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
 Biological: Placebo tablets
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.

Drug: Rescue Medication: Self-Injectable Epinephrine
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.

Drug: Rescue Medication: Loratadine tablets
Loratadine tablet 10 mg administered orally as needed for rescue medication.

Drug: Rescue Medication: Olopatadine ophthalmic drops
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.

Drug: Rescue Medication: Mometasone furoate nasal spray
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.


Outcome Measures
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Primary Outcome Measures :
  1. Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]
    The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.

  2. Number of Participants Who Experience At Least One Adverse Event (AE) [ Time Frame: Up to 54 weeks ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  3. Number of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: Up to 52 weeks ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.


Secondary Outcome Measures :
  1. Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]
    The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.

  2. Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]
    The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.

  3. Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]
    The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.

  4. Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]
    Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of AR/ARC to house dust of 1 year duration or more (with or without asthma)
  • If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study
  • Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

  • Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
  • History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
  • Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
  • Received an immunosuppressive treatment within 3 months prior to screening
  • Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists [SABAs]) at any time within 3 months prior to screening
  • Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening
  • History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen
  • History of chronic urticaria and/or angioedema within 2 years prior to screening
  • History of chronic sinusitis during 2 years prior to screening
  • Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study
  • Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening
  • Previous exposure to MK-8237
  • Receiving ongoing treatment with any specific immunotherapy at screening
  • Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine
  • Unable to meet medication washout requirements prior to screening
  • Unable or unwilling to comply with the use of self-injectable epinephrine
  • Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study
  • Likely to travel for extended periods of time during the efficacy assessment period
  • Participating in a different investigational study at any site during this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700192


Sponsors and Collaborators
ALK-Abelló A/S
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01700192    
Other Study ID Numbers: P05607
MK-8237-001 ( Other Identifier: Merck Protocol ID )
First Posted: October 4, 2012    Key Record Dates
Results First Posted: March 3, 2017
Last Update Posted: September 15, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Loratadine
Olopatadine Hydrochloride
Epinephrine
 Ophthalmic Solutions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics